Prostatic NeoplasmsVITALITENCT05266313
Contributions of a Paramedical Approach in the Prevention and Treatment of Side Effects Associated With Radical Prostatectomy
A study testing Oncosexology program in people with Prostatic Neoplasms, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
The paramedic urology team at Martinique University Hospital has developed a "personalized rehabilitation oncosexology program for patients undergoing radical prostatectomy (RP) for localized prostate cancer". Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Oncosexology program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteMartinique
- Study dates
- 31 Mar 2022to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men diagnosed with localized prostate cancer and consulting in the urology department of Mangot Vulcin site of the Martinique University Hospital
- Patients newly diagnosed for prostate cancer and who will benefit from radical prostatectomy (regardless the technique : laparotomy, laparoscopy or robot-assisted micro-invasive surgery)
- Fluent in French or Creole
- Patients who give consent
- Patients affiliated to social security
Who cannot join
- Patients diagnosed with another tumor
- Person under legal protection
Trial locations and contacts
1 site in 1 country.
Martinique1 site
Centre Hospitalier Universitaire de Martinique
Fort-de-France, 97261
About this study
Official title: Contributions of a Paramedical Approach in the Prevention and Treatment of Side Effects Associated With Radical Prostatectomy (RP): "Vitality", an Onco-sexology Program
The paramedic urology team at Martinique University Hospital has developed a "personalized rehabilitation oncosexology program for patients undergoing radical prostatectomy (RP) for localized prostate cancer". The aim of this project is to assess the effectiveness of this program by comparing the sexual quality of life 1 year after surgery between patients participating and those who do not.
Read the detailed description
80% of patients undergoing radical prostatectomy report urinary incontinence and erectile dysfunction [Johanssen et al. 2011. Scandinavian Prostate Cancer Group Study]. In the West Indies, the incidence of prostate cancer is one of the highest in the world (World-standardized incidence in Martinique is 164.5 versus 88.8 per 100,000 person-years in Metropolitan France). Over 2007-2014 an average 530 new cases of prostate cancer were diagnosed each year in Martinique, representing 55% of all male cancers [Regional estimates report Public Health France, January 2018]. The prostate is a symbol of male vulnerability [French Association of Urology-Global Market Research and Public Opinion Specialist, 2006]. For other authors, virility is above all a cultural representation, and the "crisis of virility", a recomposition of male identity. Surgery on a sexual organ can alter body image and masculinity. According to Colson et al., patients treated for prostate cancer and their partners clearly place sex in first place in the importance of quality of life domains.
- Conditions
- Prostatic Neoplasms
- Being tested
- Oncosexology program
- Keywords
- Prostatic Neoplasms, Oncosexology, Paramedics, Sexual rehabilitation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncosexology programBehavioural
Thematic workshops throughout the year
| Study group | Role | What they receive |
|---|---|---|
| Oncosexology program | Experimental | Several workshops before and after the radical prostatectomy Receives: Behavioral: Oncosexology program |
| Usual care | No intervention | Usual care of the urology department for patients with prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sexual Quality of Life: Questionnaire
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
Measured: Before the radical prostatectomy
Evaluation of sexual function: Questionnaire
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
Measured: Before the radical prostatectomy
Evaluation of sexual Quality of Life: Questionnaire
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
Measured: 1 Month after the radical prostatectomy
Evaluation of sexual function: Questionnaire
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
Measured: 1 Month after the radical prostatectomy
Evaluation of sexual Quality of Life: Questionnaire
Administration of sexual of life questionnaire (SEAR for self-esteem and couple relationship)
Measured: 12 months after the radical prostatectomy
Evaluation of sexual function: Questionnaire
Administration of sexual function questionnaire (IIEF-type validated questionnaires)
Measured: 12 months after the radical prostatectomy
Secondary outcomes (4)
Evaluation of quality of life in its multidimensional aspect
Administration of quality of life questionnaire (EORTC QLC C30 questionnaires)
Measured: Before the radical prostatectomy
Evaluation of quality of life for localized forms of prostate cancer
Administration of QLQ-PR25 questionnaire (specific module intended for localized forms of prostate cancer. It is complementary to QLQ-C30 and better suited to measure the side effects of treatment.)
Measured: Before the radical prostatectomy
Evaluation of quality of life in its multidimensional aspect
Administration of quality of life questionnaire (EORTC QLC C30 questionnaires)
Measured: 12 Month after the radical prostatectomy
Evaluation of quality of life for localized forms of prostate cancer
Administration of QLQ-PR25 questionnaire ((specific module intended for localized forms of prostate cancer. It is complementary to QLQ-C30 and better suited to measure the side effects of treatment.)
Measured: 12 Month after the radical prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start31 Mar 2022
- Primary completion10 Jun 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266313
- Sponsor's protocol ID
- 21_RIPH2-06
- Acronym
- VITALITE
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No